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A phase 2b, multinational, randomized, double-blind study to investigate the efficacy and safety of redasemtide (S 005151) compared with placebo in adult participants with acute ischemic stroke

A phase 2b, randomized, double-blind study of redasemtide (S-005151) in adult participants with acute ischemic stroke (REvive)

Gomez Juan Carlos

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

shionogiclintrials-admin@shionogi.co.jp

Corporate Communications Department

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Not Recruiting

May. 17, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Male or female adults >= 18 years of age (or complies with country-specific regulatory requirements) at the time of obtaining informed consent
- Diagnosis of supratentorial (including anterior and posterior circulation) ischemic stroke as the main infarction site, confirmed by computed tomography (CT) scan or magnetic resonance imaging (MRI) at the time of screening. The CT imaging criteria are hypodensity, perfusion deficit, or vessel occlusion in the anterior or posterior circulation
- Able to initiate study intervention within 25 hours of stroke onset (if the onset time is unknown, the last time at which the participant was known to be healthy is regarded as the onset time ['last known to be well'])
(cohort A only)
- Determined by the investigator to not be eligible for systemic thrombolysis and/or mechanical recanalization therapy (ie, mechanical thrombectomy, local fibrinolytic therapy as per local standard of care) for the current stroke. (Note: Participants who underwent mechanical thrombectomy, but for whom a stent could not be placed to reach the occluded vessel site may be eligible for this study.)
- If a participant is not eligible for systemic thrombolysis and/or mechanical recanalization therapy, Screening and Baseline NIHSS score of 6 to 22 is required (inclusive) and must be stable
(cohort B only)
- Determined by the investigator to be eligible for systemic thrombolysis and/or mechanical recanalization therapy
- In a participant who is eligible to receive or has received concomitant systemic thrombolysis and/or mechanical recanalization therapy, the NIHSS score must be 6 to 22 at Screening prior to systemic thrombolysis and/or mechanical recanalization therapy and the second /Baseline NIHSS score must be 6 to 22 and should be done after systemic thrombolysis and/or mechanical recanalization therapy

- A severe decrease in consciousness level (defined as NIHSS item 1a score 3: Not alert, responds only with reflex motor or autonomic effects, or totally unresponsive, flaccid, and areflexic)
- Disability corresponding to a mRS score of >= 2 before the onset of stroke
- A history of stroke (excluding transient ischemic attack), history of or current intracranial hemorrhage, or head trauma that caused neurological effects within 90 days prior to obtaining informed consent
- Participants with an ischemic stroke in cerebellum and/or brain stem as the main infarction site
- Diagnosis of a current transient ischemic attack
- Unable to undergo either CT or MRI
- Considered by the investigator to be inappropriate to participate due to a history or complication of serious cardiovascular disease within 1 month of screening (eg, history of acute myocardial infarction, current acute myocardial infarction, uncontrollable heart failure, infective endocarditis requiring treatment, or acute aortic dissection, or requiring or likely to require hospitalization for severe arrhythmia during the study)
- Blood glucose level < 50 or > 400 mg/dL after glycemic control
- Systolic blood pressure >= 220 mm Hg or diastolic blood pressure >= 120 mm Hg after antihypertensive treatment
- Current or ongoing anticancer treatment; however, nonmelanoma skin cancer or lesions equivalent to intramucosal cancer or carcinoma in situ curable by endoscopic resection may be eligible for this study

Both

Patient with acute ischemic stroke

S-005151 (0.75, 1.5 mg/kg) or placebo are administered intravenously

mRS score at Day 90

+81-3-5213-0028

April. 14, 2023

No

North America/EMEA/APAC